Assess Effect of Omega-3 Fish Oil in Patients With Severe Acute PancreatitisPhase 2NCT01745861
Effects Of Fish Oil Emulsion On Severe Acute Pancreatitis Patients
A Phase 2 study testing Lipidem (Omega-3 fish oil lipid emulsion) and Lipofundin® MCT/LCT 20% in people with Assess Effect of Omega-3 Fish Oil in Patients With Severe Acute Pancreatitis, run by University Hospitals, Leicester at 1 site in United Kingdom.
Trial summary
The incidence of acute pancreatitis in UK has risen sharply over the past 40 years. Recent reports suggest that 56.5 per 100 000 of the population will suffer from AP annually; this figure is more than double the highest previous estimated incidence. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Assess Effect of Omega-3 Fish Oil in Patients With Severe Acute Pancreatitis
- What is being tested?
- Lipidem (Omega-3 fish oil lipid emulsion) and Lipofundin® MCT/LCT 20%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2010to Feb 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Conscious patients between age of 18-90 admitted to the Leicester General hospital with severe acute pancreatitis proven by:
- compatible clinical features (abdominal pain with or without vomiting);
- associated with elevated serum amylase levels (≥3 normal value) (≥300 iu/l);
- one or more of the severity criteria as outlined in the Atlanta severity criteria or modified glasgow acute pancreatitis severity score ≥3
Who cannot join
- Patients unconscious or unable to consent.
- Patients under 18 years old or above 90 years old
- Hypersensitivity to fish, egg or soy protein or other active substances of the TPN.
- Uncontrolled hyperlipidaemia
- Severe primary blood coagulation disorder
- Acute pancreatitis accompanied with hyperlipidaemia
Show all 12Show fewer
- Ketoacidosis
- Acute thromboembolic disease
- Severe liver failure
- Acute phase of myocardial infarction or stroke
- Pregnancy and lactation
- Severe renal failure without access to haemofiltration or dialysis
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leicester General Hospital, University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, LE5 4PW
About this study
Official title: Randomised Controlled Trial On The Effects Of Parenteral Fish Oil Emulsion In Patients With Severe Acute Pancreatitis
The incidence of acute pancreatitis in UK has risen sharply over the past 40 years. Recent reports suggest that 56.5 per 100 000 of the population will suffer from AP annually; this figure is more than double the highest previous estimated incidence. In the majority of patients the condition is mild, but about 25% of patients suffer a severe attack and between 30 and 50% of these patients dies. The usual cause of death is multiple organ failure secondary to systemic leukocyte activation (mainly neutrophils), accompanied by the systemic inflammatory response syndrome (SIRS).
Studies with omega-3 fish oil have shown to control inflammatory process and improve the outcome especially in hyperinflammatory conditions.
Read more
This research will look at the effects of supplementing omega-3 fish oil to patients with severe acute pancreatitis (severe inflammation of the pancreas).
Patients with severe acute pancreatitis will be prospectively and blindly randomised into either a study group who will receive (Lipidem, lipid emulsion contains essential fatty acids and omega-3 fish oil) or a control group that will receive (Lipofundin, lipid emulsion contains only essential fatty acids and no omega-3 fish oil). Normal and standard clinical care will be provided to all patients as per the national management guidelines. Each patient will receive either Lipidem or Lipofundin emulsions daily until they are deemed fit for discharge by their own medical team or for a maximum of SEVEN days.
The main aim of this study is to examine whether lipid emulsions enriched with omega-3 fish oil could improve the clinical outcome in patients with severe acute pancreatitis.
Read the detailed description
This research project is designed to give lipid emulsion enriched with omega-3 fish oil to conscious adult patients with mental capacity to consent for themselves and with severe acute pancreatitis in Leicester General Hospital wards or units.
Potential participants with SAP will be identified by the patient's own team and referred to the researchers for consideration and eventual enrolling in the study. Unconscious patients or unable to consent for themselves will be EXCLUDED from the study.
Randomization:
Patients will be randomised to receive Lipidem 200 mg/ml OR Lipofundin MCT/LCT 20% lipid emulsion from random number tables. Randomization, blinding procedure (over labeling) will be conducted by an independent licensed pharmaceutical unit.
- Being tested
- Lipidem (Omega-3 fish oil lipid emulsion), Lipofundin® MCT/LCT 20%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipidem (Omega-3 fish oil lipid emulsion)Dietary supplement
Lipidem 200 mg/ml daily infusion for 7 days maximum
Lipofundin® MCT/LCT 20%Dietary supplement
Lipofundin® MCT/LCT 20% daily infusion for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Lipidem® (BBraun) | Active comparator | Lipid emulsion containing medium chain triglycerides (MCT), long chain triglyceride (LCT) and Omega-3 fatty acid (fish oil) Receives: Dietary Supplement: Lipidem (Omega-3 fish oil lipid emulsion) |
| Lipofundin® MCT/LCT 20% | Placebo comparator | Lipid emulsion containing medium and long chain triglycerides Receives: Dietary Supplement: Lipofundin® MCT/LCT 20% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of the CRP by 20% from the control group
Measured: Day 7 post infusion
Secondary outcomes (5)
Progression in the Sequential Organ Failure Assessment (SOFA) Score
Measured: On days 1, 2, 3, 5 and 7 post infusion
Progression in the Multiple Organ Dysfunction Score (MODS)
Measured: On days 1, 2, 3, 5 and 7 post infusion
Progression in the Systemic Inflammatory Response Syndrome
Measured: On days 1, 2, 3, 5 and 7 post infusion
Progression in the inflammatory and anti-inflammatory mediators (IL-1RA, IL-10, IL-6, IL-18, TNF-a, ICAM-1, IL-10 etc...).
Measured: On days 1, 2, 3, 5 and 7 post infusion
Escalation of care to high dependency or intensive care unit and length of hospital stay
Measured: On days 1, 2, 3, 5 and 7 post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startJun 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Assess Effect of Omega-3 Fish Oil in Patients With Severe Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mr. Ashley Dennison, MD FRCS, Principal investigator, Leicester General Hospital, University Hospitals of Leicester NHS TrustMatthew Metcalfe, MD FRCS, Study chair, Leicester General Hospital, University Hospitals of Leicester NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745861
- Sponsor's protocol ID
- SAP version 3 26-05-2011
- Status last verified
- Dec 2012
- First submitted
- 13 Nov 2012
- Last updated
- 10 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Foitzik T, Eibl G, Schneider P, Wenger FA, Jacobi CA, Buhr HJ. Omega-3 fatty acid supplementation increases anti-inflammatory cytokines and attenuates systemic disease sequelae in experimental pancreatitis. JPEN J Parenter Enteral Nutr. 2002 Nov-Dec;26(6):351-6. doi: 10.1177/0148607102026006351.
PubMed 12405646Morlion BJ, Torwesten E, Lessire H, Sturm G, Peskar BM, Furst P, Puchstein C. The effect of parenteral fish oil on leukocyte membrane fatty acid composition and leukotriene-synthesizing capacity in patients with postoperative trauma. Metabolism. 1996 Oct;45(10):1208-13. doi: 10.1016/s0026-0495(96)90237-1.
PubMed 8843174Hardman WE. (n-3) fatty acids and cancer therapy. J Nutr. 2004 Dec;134(12 Suppl):3427S-3430S. doi: 10.1093/jn/134.12.3427S.
PubMed 15570049Roulet M, Frascarolo P, Pilet M, Chapuis G. Effects of intravenously infused fish oil on platelet fatty acid phospholipid composition and on platelet function in postoperative trauma. JPEN J Parenter Enteral Nutr. 1997 Sep-Oct;21(5):296-301. doi: 10.1177/0148607197021005296.
PubMed 9323693Serhan CN, Clish CB, Brannon J, Colgan SP, Chiang N, Gronert K. Novel functional sets of lipid-derived mediators with antiinflammatory actions generated from omega-3 fatty acids via cyclooxygenase 2-nonsteroidal antiinflammatory drugs and transcellular processing. J Exp Med. 2000 Oct 16;192(8):1197-204. doi: 10.1084/jem.192.8.1197.
PubMed 11034610Lee TH, Hoover RL, Williams JD, Sperling RI, Ravalese J 3rd, Spur BW, Robinson DR, Corey EJ, Lewis RA, Austen KF. Effect of dietary enrichment with eicosapentaenoic and docosahexaenoic acids on in vitro neutrophil and monocyte leukotriene generation and neutrophil function. N Engl J Med. 1985 May 9;312(19):1217-24. doi: 10.1056/NEJM198505093121903.
PubMed 2985986Al-Leswas D, Eltweri AM, Chung WY, Arshad A, Stephenson JA, Al-Taan O, Pollard C, Fisk HL, Calder PC, Garcea G, Metcalfe MS, Dennison AR. Intravenous omega-3 fatty acids are associated with better clinical outcome and less inflammation in patients with predicted severe acute pancreatitis: A randomised double blind controlled trial. Clin Nutr. 2020 Sep;39(9):2711-2719. doi: 10.1016/j.clnu.2018.04.003. Epub 2018 Apr 27.
PubMed 32921364
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial On The Effects Of Parenteral Fish Oil Emulsion In Patients With Severe Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT01745861
- Acronym / sponsor ID
- SAP version 3 26-05-2011
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 10 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The incidence of acute pancreatitis in UK has risen sharply over the past 40 years. Recent reports suggest that 56.5 per 100 000 of the population will suffer from AP annually; this figure is more than double the highest previous estimated incidence. In the majority of patients the condition is mild, but about 25% of patients suffer a severe attack and between 30 and 50% of these patients dies. The usual cause of death is multiple organ failure secondary to systemic leukocyte activation (mainly neutrophils), accompanied by the systemic inflammatory response syndrome (SIRS).
Studies with omega-3 fish oil have shown to control inflammatory process and improve the outcome especially in hyperinflammatory conditions.
This research will look at the effects of supplementing omega-3 fish oil to patients with severe acute pancreatitis (severe inflammation of the pancreas).
Patients with severe acute pancreatitis will be prospectively and blindly randomised into either a study group who will receive (Lipidem, lipid emulsion contains essential fatty acids and omega-3 fish oil) or a control group that will receive (Lipofundin, lipid emulsion contains only essential fatty acids and no omega-3 fish oil). Normal and standard clinical care will be provided to all patients as per the national management guidelines. Each patient will receive either Lipidem or Lipofundin emulsions daily until they are deemed fit for discharge by their own medical team or for a maximum of SEVEN days.
The main aim of this study is to examine whether lipid emulsions enriched with omega-3 fish oil could improve the clinical outcome in patients with severe acute pancreatitis.
Detailed description
This research project is designed to give lipid emulsion enriched with omega-3 fish oil to conscious adult patients with mental capacity to consent for themselves and with severe acute pancreatitis in Leicester General Hospital wards or units.
Potential participants with SAP will be identified by the patient's own team and referred to the researchers for consideration and eventual enrolling in the study. Unconscious patients or unable to consent for themselves will be EXCLUDED from the study.
Randomization:
Patients will be randomised to receive Lipidem 200 mg/ml OR Lipofundin MCT/LCT 20% lipid emulsion from random number tables. Randomization, blinding procedure (over labeling) will be conducted by an independent licensed pharmaceutical unit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lipidem® (BBraun) | Active comparator | Dietary Supplement: Lipidem (Omega-3 fish oil lipid emulsion)Lipid emulsion containing medium chain triglycerides (MCT), long chain triglyceride (LCT) and Omega-3 fatty acid (fish oil) |
| Lipofundin® MCT/LCT 20% | Placebo comparator | Dietary Supplement: Lipofundin® MCT/LCT 20%Lipid emulsion containing medium and long chain triglycerides |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Conscious patients between age of 18-90 admitted to the Leicester General hospital with severe acute pancreatitis proven by:
- compatible clinical features (abdominal pain with or without vomiting);
- associated with elevated serum amylase levels (≥3 normal value) (≥300 iu/l);
- one or more of the severity criteria as outlined in the Atlanta severity criteria or modified glasgow acute pancreatitis severity score ≥3
Key exclusion criteria (12 listed)
- Patients unconscious or unable to consent.
- Patients under 18 years old or above 90 years old
- Hypersensitivity to fish, egg or soy protein or other active substances of the TPN.
- Uncontrolled hyperlipidaemia
- Severe primary blood coagulation disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipidem (Omega-3 fish oil lipid emulsion)Lipidem 200 mg/ml daily infusion for 7 days maximum | Dietary supplement | Lipidem® (BBraun) |
| Lipofundin® MCT/LCT 20%Lipofundin® MCT/LCT 20% daily infusion for 7 days | Dietary supplement | Lipofundin® MCT/LCT 20% |
Primary outcome
Reduction of the CRP by 20% from the control group
Time frame: Day 7 post infusion
5 secondary outcomes
Progression in the Sequential Organ Failure Assessment (SOFA) Score
Time frame: On days 1, 2, 3, 5 and 7 post infusion
Progression in the Multiple Organ Dysfunction Score (MODS)
Time frame: On days 1, 2, 3, 5 and 7 post infusion
Progression in the Systemic Inflammatory Response Syndrome
Time frame: On days 1, 2, 3, 5 and 7 post infusion
Progression in the inflammatory and anti-inflammatory mediators (IL-1RA, IL-10, IL-6, IL-18, TNF-a, ICAM-1, IL-10 etc...).
Time frame: On days 1, 2, 3, 5 and 7 post infusion
Escalation of care to high dependency or intensive care unit and length of hospital stay
Time frame: On days 1, 2, 3, 5 and 7 post infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2012.
- Background: PubMed 12405646Foitzik T, Eibl G, Schneider P, Wenger FA, Jacobi CA, Buhr HJ. Omega-3 fatty acid supplementation increases anti-inflammatory cytokines and attenuates systemic disease sequelae in experimental pancreatitis. JPEN J Parenter Enteral Nutr. 2002 Nov-Dec;26(6):351-6. doi: 10.1177/0148607102026006351.
- Background: PubMed 8843174Morlion BJ, Torwesten E, Lessire H, Sturm G, Peskar BM, Furst P, Puchstein C. The effect of parenteral fish oil on leukocyte membrane fatty acid composition and leukotriene-synthesizing capacity in patients with postoperative trauma. Metabolism. 1996 Oct;45(10):1208-13. doi: 10.1016/s0026-0495(96)90237-1.
- Background: PubMed 15570049Hardman WE. (n-3) fatty acids and cancer therapy. J Nutr. 2004 Dec;134(12 Suppl):3427S-3430S. doi: 10.1093/jn/134.12.3427S.
- Background: PubMed 9323693Roulet M, Frascarolo P, Pilet M, Chapuis G. Effects of intravenously infused fish oil on platelet fatty acid phospholipid composition and on platelet function in postoperative trauma. JPEN J Parenter Enteral Nutr. 1997 Sep-Oct;21(5):296-301. doi: 10.1177/0148607197021005296.
- Background: PubMed 11034610Serhan CN, Clish CB, Brannon J, Colgan SP, Chiang N, Gronert K. Novel functional sets of lipid-derived mediators with antiinflammatory actions generated from omega-3 fatty acids via cyclooxygenase 2-nonsteroidal antiinflammatory drugs and transcellular processing. J Exp Med. 2000 Oct 16;192(8):1197-204. doi: 10.1084/jem.192.8.1197.
- Background: PubMed 2985986Lee TH, Hoover RL, Williams JD, Sperling RI, Ravalese J 3rd, Spur BW, Robinson DR, Corey EJ, Lewis RA, Austen KF. Effect of dietary enrichment with eicosapentaenoic and docosahexaenoic acids on in vitro neutrophil and monocyte leukotriene generation and neutrophil function. N Engl J Med. 1985 May 9;312(19):1217-24. doi: 10.1056/NEJM198505093121903.
- Derived from this study: PubMed 32921364Al-Leswas D, Eltweri AM, Chung WY, Arshad A, Stephenson JA, Al-Taan O, Pollard C, Fisk HL, Calder PC, Garcea G, Metcalfe MS, Dennison AR. Intravenous omega-3 fatty acids are associated with better clinical outcome and less inflammation in patients with predicted severe acute pancreatitis: A randomised double blind controlled trial. Clin Nutr. 2020 Sep;39(9):2711-2719. doi: 10.1016/j.clnu.2018.04.003. Epub 2018 Apr 27.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mr. Ashley Dennison, MD FRCS principal investigator
Leicester General Hospital, University Hospitals of Leicester NHS Trust
Matthew Metcalfe, MD FRCS study chair
Leicester General Hospital, University Hospitals of Leicester NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lipidem (Omega-3 fish oil lipid emulsion) and Lipofundin® MCT/LCT 20% in people with Assess Effect of Omega-3 Fish Oil in Patients With Severe Acute Pancreatitis, run by University Hospitals, Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of the CRP by 20% from the control group (time frame: Day 7 post infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01745861, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2012.